COMPANY

B. Braun

FDA-approved therapeutic company FDA-cleared device company Clinical Phase 1

Profile checked Oct 10, 2026

Keywords: Enterostomy Pressure Ulcer Knee Arthroplasty Colostomy Familial Hypercholesterolemia In-stent Coronary Artery Restenosis Coronary Artery Restenosis In-stent Restenosis Complications Associated With Device Stoma Ileostomy Stoma Colostomy Wound of Lower Leg (Physical Finding) Postoperative Infection Ostomy Severe Sepsis Hypercholesterolemia Colostomy Stoma Therapeutic Irrigation Intermittent Urethral Catheterization Hypovolemia Respiratory Failure Diabetic Foot Ulcer Third Degree Burns MRSA - Methicillin Resistant Staphylococcus Aureus Infection MRSA Colonization Critical Illness Diabetic Complications Askina Calgitrol paste Linovera®

32Trials (company is sponsor)

Timeline

2023-12 Trial start —: Performance and Safety of Lubri-cream for Pain Minimization During Urethral Catheterization and Cystoscopy source ↗
Nov 14, 2023 Trial start —: PMCF Study on the Safety of Linovera® for the Treatment of Category-I Pressure Ulcers/Injuries source ↗
Feb 10, 2023 Trial start Not phased (device or behavioral study): Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment source ↗
Dec 15, 2022 Trial start —: PMCF Study on the Safety of Linovera Emulsion for the Prevention of Cat-1 Pressure Ulcers, Vascular and DFU source ↗
Apr 5, 2022 Trial start Phase 1: Pharmacokinetics and Safety of Cefazolin 3gm DUPLEX in Adults source ↗
Apr 1, 2022 Trial start —: Safety and Performance of Flexima®/Softima® Stoma Appliances in Enterostomy Patients source ↗
Jan 24, 2020 Trial start Not phased (device or behavioral study): Effect of B. Braun Peripheral Advantage Program on Complications, Indwell Time and First Stick Success of PIVC Therapy source ↗
2020-01 Trial start —: BE1 Study Spain - CAPSULE SYSTEM FOR COLOSTOMATES source ↗
May 8, 2018 Trial start Not phased (device or behavioral study): Study to Evaluate the Performance of a New 2-piece Ostomy Appliance vs. Flexima® 3S in Patients With Enterostomy source ↗
Feb 20, 2018 Trial start Not phased (device or behavioral study): Prontosan Quality of Life Study in Patients With Chronic Leg Wound(s) source ↗
Nov 20, 2017 Trial start Phase 4: Safety of 1 g and 2 g of Cefazolin in Pediatric Subjects source ↗
Aug 23, 2017 Trial start —: Study on the Stoma Appliance Flexima®/Softima® 3S source ↗
Jun 1, 2017 Trial start Not phased (device or behavioral study): Multicenter Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy source ↗
Nov 10, 2016 Trial start Not phased (device or behavioral study): Pilot Study Evaluating the Use of a New Device for Transanal Irrigation in Patient With Bowel Disorders source ↗
Sep 2, 2016 Trial start Not phased (device or behavioral study): Clinical Study Evaluating the Safety of a New Catheter for Urinary Intermittent Catheterization in Self Catheterized Patients source ↗
Jul 1, 2016 Trial start —: VEGA System® Study in the Total Knee Arthroplasty source ↗
2016-06 Trial start Phase 3: Study on the Efficacy and Safety of Gelaspan source ↗
May 26, 2016 Trial start —: Non-Interventional Consecutive and Prospective Study of e.Motion® PS Pro Prosthesis in the Total Knee Artroplasty source ↗
2015-11 Trial start Not phased (device or behavioral study): Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy source ↗
2015-06 Trial start Not phased (device or behavioral study): Multicenter and Open Pilot Clinical Study on the Safety of a New One-piece Convex Appliance in Patients With Enterostomy source ↗
2013-10 Trial start Phase 4: Randomized Controlled Multicenter Study to Evaluate the Performance of Flexima® Active vs. Sensura® in Patients With Colostomy source ↗
2013-04 Trial start Not phased (device or behavioral study): Askina Calgitrol Paste Diabetic Foot Ulcers source ↗
2013-04 Trial start Phase 3: Askina Calgitrol Paste Burns source ↗
2013-03 Trial start Phase 1: Pediatric Cefazolin PK Study source ↗
2012-03 Trial start Not phased (device or behavioral study): Prontosan Versus Saline in the Cleansing of Chronic Leg Ulcers in Diabetic Patients source ↗

Showing 25 of 32 dated events.

Clinical trials (lead sponsor) 32

Record	Title	Phase	Status	Start	Primary completion
NCT05205486	Pharmacokinetics and Safety of Cefazolin 3gm DUPLEX in Adults	Phase 1	Completed	Apr 5, 2022	Jul 13, 2023 (actual)
NCT00916643	Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy	Phase 4	Completed	1999-12	2009-09 (actual)
NCT06183086	PMCF Study on the Safety of Linovera® for the Treatment of Category-I Pressure Ulcers/Injuries	Not listed	Unknown status (ClinicalTrials.gov)	Nov 14, 2023	2024-11 (estimated)
NCT06101121	Performance and Safety of Lubri-cream for Pain Minimization During Urethral Catheterization and Cystoscopy	Not listed	Unknown status (ClinicalTrials.gov)	2023-12	2024-09 (estimated)
NCT05763654	PMCF Study on the Safety of Linovera Emulsion for the Prevention of Cat-1 Pressure Ulcers, Vascular and DFU	Not listed	Unknown status (ClinicalTrials.gov)	Dec 15, 2022	2023-12 (estimated)
NCT05093244	Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment	Not phased (device or behavioral study)	Withdrawn	Feb 10, 2023	Feb 10, 2023 (actual)
NCT04048863	Effect of B. Braun Peripheral Advantage Program on Complications, Indwell Time and First Stick Success of PIVC Therapy	Not phased (device or behavioral study)	Terminated	Jan 24, 2020	Jul 27, 2021 (actual)
NCT05373888	Safety and Performance of Flexima®/Softima® Stoma Appliances in Enterostomy Patients	Not listed	Unknown status (ClinicalTrials.gov)	Apr 1, 2022	Mar 31, 2023 (estimated)
NCT03369756	Prontosan Quality of Life Study in Patients With Chronic Leg Wound(s)	Not phased (device or behavioral study)	Terminated	Feb 20, 2018	Sep 25, 2019 (actual)
NCT03231228	Safety of 1 g and 2 g of Cefazolin in Pediatric Subjects	Phase 4	Terminated	Nov 20, 2017	Jul 31, 2019 (actual)
NCT04239183	BE1 Study Spain - CAPSULE SYSTEM FOR COLOSTOMATES	Not listed	Unknown status (ClinicalTrials.gov)	2020-01	2021-01 (estimated)
NCT02934802	Non-Interventional Consecutive and Prospective Study of e.Motion® PS Pro Prosthesis in the Total Knee Artroplasty	Not listed	Unknown status (ClinicalTrials.gov)	May 26, 2016	2025-02 (estimated)
NCT02944409	VEGA System® Study in the Total Knee Arthroplasty	Not listed	Unknown status (ClinicalTrials.gov)	Jul 1, 2016	2025-02 (estimated)
NCT03133585	Study on the Stoma Appliance Flexima®/Softima® 3S	Not listed	Unknown status (ClinicalTrials.gov)	Aug 23, 2017	Jun 30, 2021 (estimated)
NCT01312675	S.A.F.E.BT System Extracorporeal Treatment With DIAPACT CRRT	Not phased (device or behavioral study)	Terminated	2011-04	2015-03 (actual)
NCT00526058	(H.E.L.P.)Apheresis Therapy to Compare the Reduction of LDL (Low Density Lipoprotein) Cholesterol	Not phased (device or behavioral study)	Completed	2007-08	2008-10 (actual)
NCT03572673	Study to Evaluate the Performance of a New 2-piece Ostomy Appliance vs. Flexima® 3S in Patients With Enterostomy	Not phased (device or behavioral study)	Unknown status (ClinicalTrials.gov)	May 8, 2018	2019-04 (estimated)
NCT03108105	Multicenter Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy	Not phased (device or behavioral study)	Completed	Jun 1, 2017	Nov 7, 2017 (actual)
NCT02944916	Pilot Study Evaluating the Use of a New Device for Transanal Irrigation in Patient With Bowel Disorders	Not phased (device or behavioral study)	Completed	Nov 10, 2016	Jun 15, 2017 (actual)
NCT02911051	Clinical Study Evaluating the Safety of a New Catheter for Urinary Intermittent Catheterization in Self Catheterized Patients	Not phased (device or behavioral study)	Completed	Sep 2, 2016	May 3, 2017 (actual)
NCT02808325	Study on the Efficacy and Safety of Gelaspan	Phase 3	Completed	2016-06	2017-06 (actual)
NCT01904357	Pediatric Cefazolin PK Study	Phase 1	Completed	2013-03	2013-08 (actual)
NCT02602236	Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy	Not phased (device or behavioral study)	Terminated	2015-11	2016-10 (actual)
NCT02507726	Multicenter and Open Pilot Clinical Study on the Safety of a New One-piece Convex Appliance in Patients With Enterostomy	Not phased (device or behavioral study)	Completed	2015-06	2016-09 (actual)
NCT02526862	Prevention of Pressure Ulcers in Patients Under Non-Invasive Mechanical Ventilation	Phase 4	Completed	2012-02	2013-08 (actual)
NCT01912092	Askina Calgitrol Paste Diabetic Foot Ulcers	Not phased (device or behavioral study)	Completed	2013-04	2014-07 (actual)
NCT02223104	Randomized Controlled Multicenter Study to Evaluate the Performance of Flexima® Active vs. Sensura® in Patients With Colostomy	Phase 4	Completed	2013-10	2014-10 (actual)
NCT01911858	Askina Calgitrol Paste Burns	Phase 3	Withdrawn	2013-04	2013-12 (estimated)
NCT01400308	Effectiveness of Two Protocols for Corporal Decolonization in Patients Colonized by Methicillin Resistant Staphylococcus Aureus (MRSA)	Phase 4	Terminated	2010-02	2011-12 (actual)
NCT00396461	ICULIP, Influence of Two Lipid Emulsions in the Nosocomial Infection in Critical Patients	Phase 4	Terminated	2006-11	2010-09 (actual)
NCT01121354	Pharmacokinetics and Safety of Cefazolin 2g in DUPLEX	Phase 1	Completed	2009-12	2010-02 (actual)
NCT01554644	Prontosan Versus Saline in the Cleansing of Chronic Leg Ulcers in Diabetic Patients	Not phased (device or behavioral study)	Withdrawn	2012-03	2012-09 (estimated)